Kornimate/medical-research-clean huggingface dataset:
guided placement of crt-leads

Conditions: Heart Failure

Summary: in this open, prospective, randomized, parallel group, german-american, two-center, phase i study the standard-approach crt-implantation will be compared to a guided crt-implantation after determining the site of latest contraction and placement of the electrode as close as possible to this site, using a 5-step-scheme of imaging methods determining the site of latest contraction prior to implantation.

patients will be allocated to two groups with either 1. guided implantation of the left ventricular lead 2. empirical implantation of the left ventricular lead (current clinical standard) for treatment group a) the target vessel, which is the vessel with smallest distance between rlc and cvs is determined in advance and provided to the implanting physician. in case, this vessel is not amenable for lead positioning, a second vessel which is the second closest to the rlc is defined. for treatment group b), the physician has to choose the vessel where to place the electrode without knowing the exact spatial orientation between that particular side-branch and the rlc. in all patients, standard biventricular devices and leads are to be used. aspects that are evaluated are: 1. technical success in placing the electrode in the target vessel. 2. failure due to dislocation during the implantation procedure or phrenic nerve stimulation. also, procedure duration, radiation exposure, and complications occurring during the procedure as well as post- operatively will be documented.

Eligibility criteria:
inclusion criteria: * congestive heart failure, * ejection fraction \<35%, * complete left bundle branch block \>120ms, * nyha ii,iii or iv exclusion criteria: * patients not fulfilling the inclusion criteria or not capable/mental able to understand and follow the instructions; * impaired kidney function (gfr \<30ml/min; * pregnant or breastfeeding women

Keywords: heart failure; ef<35%; nyha ii, iii or iv
pecomas: natural history and prognostic factors

Conditions: PEComas

Summary: perivascular epithelioid cell tumors are rare and characterized by the expression of myomelanocytic markers. they belong to a complex tumor family that includes angiomyolipomas, lymphangioleiomyomatosis and other soft-tissue tumors. given their rarity, the natural history of pecomas is not yet understood, and a comprehensive classification that integrates clinical, pathological and molecular features has not been achieved as of today. this study is a national multicenter retrospective study to better understand the natural history of pecomas, excluding lymphangioleiomyomatosis and classic triphasic angiomyolipomas. the primary purpose is the identification of prognostic markers impacting the relapse. secondaries purposes are to identify prognostic markers impacting the overall survival and to have a better understanding of natural history


Eligibility criteria:
inclusion criteria: * major patient (≥18 years old) * minor patient (1 to 17 years old) * pecomas diagnosed in france between 1990 and 2018 and read back by a pathologist referent of sarcomas * patient having agreed to the use of his medical data for the purpose of this research. * parental authorities having given their agreement for the reuse of their child's medical data for the purpose of this research. exclusion criteria: * opposition of the patient (or his legal representative) to the reuse of his data for the purposes of this research * impossibility of giving the subject clear information * patient under safeguard of justice * patient under guardianship * lymphangioleiomyomatosis * classic triphasic angiomyolipoma
feasibility study: self-guided icbt for mothers with postpartum depression.

Conditions: Postpartum Depression; Internet-based Intervention

Summary: the purpose of this study is to conduct a feasibility study to test the study procedure and a newly developed self-guided internet-based cognitive behavioral therapy program for mothers with postpartum depression.

the aim of the feasibility study is twofold: 1) to test the feasibility of the study, and 2) to test the acceptability of the internet-based cognitive behavioral therapy program and to minimize dropout. the study will be conducted as a mixed-method process evaluation. twenty mothers will be included in the study. after being informed about the study and its potential, all patients who give written informed consent will be randomized in a 1:1 ratio into either the control group, receiving treatment as usual, or the intervention group, receiving treatment as usual plus the icbt program icare. the intervention period will last for two months. after the intervention period, investigators will use a survey distributed from redcap to measure its feasibility, participants' satisfaction with it, and acceptability. after the two-month intervention period, semi-structured interviews will be conducted with participants from both the intervention and control groups to gather qualitative insights. this feasibility study will also provide a preliminary evaluation of the intervention's impact. the findings from this pilot study will inform the design of the subsequent randomized controlled trial (rct) and guide any necessary modifications to the treatment program and associated procedures.

Eligibility criteria:
inclusion criteria: * edinburgh postnatal depression scale (epds) score 11-18 * ≥age 18 * access to the internet exclusion criteria: * thoughts of self-harm≥2 on epds item 10 * do not understand danish language, * substance abuse or dependence * alcohol abuse, defined as a weekly consumption of alcohol exceeding ten units, * physical condition requiring frequent hospitalization like dialysis, chemotherapy, or blood transfusion, * a diagnosis of schizophrenia or other psychotic disorders.

Keywords: cognitive behavioral therapy postpartum depression web-based intervention
study to evaluate the pharmacokinetics, safety, and antiviral activity of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (e/c/f/taf) single tablet regimen (str) in hiv-1 infected antiretroviral treatment-naive adolescents and virologically suppressed children

Conditions: Acquired Immune Deficiency Syndrome (AIDS); HIV Infections

Summary: the primary objectives of cohort 1 are to evaluate the steady state pharmacokinetics (pk) for elvitegravir (evg) and tenofovir alafenamide (taf) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (e/c/f/taf) str (part a) and to evaluate the safety and tolerability of e/c/f/taf str through week 24 (part b) in human immunodeficiency virus - 1 (hiv-1) infected, antiretroviral (arv) treatment-naive adolescents. the primary objectives of cohort 2 are to evaluate the pk of evg and taf in virologically suppressed hiv-1 infected children 6 to \< 12 years of age weighing ≥ 25 kg administered e/c/f/taf str (part a) and to evaluate the safety and tolerability of e/c/f/taf str through week 24 in virologically suppressed hiv-1 infected children 6 to \< 12 years of age weighing ≥ 25 kg (part b). the primary objectives of cohort 3 are to evaluate the pk of evg and taf and confirm the dose of the str, and to evaluate the safety and tolerability of e/c/f/taf low dose (ld) str in virologically suppressed hiv-1 infected children ≥ 2 years of age and weighing ≥ 14 to \< 25 kg.


Eligibility criteria:
key inclusion criteria: * cohort 1 * 12 years to \< 18 years of age at baseline * weight greater than or equal to 35 kg (77 lbs) * plasma hiv-1 ribonucleic acid (rna) levels of ≥ 1,000 copies/ml at screening (roche cobas taqman v2.0) * screening genotype report shows sensitivity to evg, ftc and tenofovir (tfv) * no prior use of any approved or experimental anti-hiv-1 drug for any length of time * cohort 2 * 6 years to \< 12 years of age at baseline * weight greater than or equal to 25 kg (55 lbs) * plasma hiv-1 rna of \ 50 copies/ml) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without documented history of resistance to any component of e/c/f/taf str. * cohort 3 * age at baseline: ≥ 2 years old * weight at screening: ≥ 14 kg (31 lbs) to \< 25 kg (55 lbs) * plasma hiv-1 rna: \ 50 copies/ml) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without prior history of resistance to any component of e/c/f/taf str key exclusion criteria: * hepatitis b or hepatitis c virus infection * evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit. * individuals experiencing decompensated cirrhosis * pregnant or lactating females note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: adolescents hiv-1 hiv treatment-naive virologically suppressed
qualior feasibility and efficacy of a supervised home-based standard physical exercise program

Conditions: Home Based Standardised Adapted Physical Activity Programme; Patients Taking Oral Targeted Therapy for Metastatic Cancer

Summary: this phase ii-iii study will be randomized (2:1) patients starting first-line oral targeted therapies (ott) for metastatic cancer between an individualized supervised physical exercise programs (spep) by a personal coach, and recommended physical exercises via a booklet. eligible patients will have received ≤2 lines of metastatic chemotherapy, eastern cooperative oncology group performance status (ecog ps) ≤2, controlled pain (visual analogue scale (vas) \<3/10), and life expectancy ≥3 months.


Eligibility criteria:
inclusion criteria: 1. patient's ≥18 years old. 2. patient treated for a metastatic solid tumour within the following 4 cohorts: breast cancer, kidney cancer, lung cancer, and other tumours treated with oral targeted therapies (including melanomas, sarcomas, hepatic sarcomas, and colon cancers). 3. patients starting first-line oral targeted therapy, with market authorisation. the targeted therapy may be associated with hormonal therapy. 4. patients may have been treated with immunotherapy. 5. patients may have received chemotherapy (≤2 lines) for their metastatic disease. 6. life expectancy of ≥3 months. 7. ecog performance status ≤2. 8. patients able to comply with the constraints of the spep protocol. 9. pain under control (vas ˂3; 0-10 scale). 10. haemoglobin level ≥9 g/dl. 11. patient must have signed the informed consent form before any study-related procedures. 12. patients must have public health insurance coverage. exclusion criteria: 1. patient receiving an injectable targeted therapy. 2. patient previously treated by more than 2 lines of treatment (previous treatment with cytokines are allowed) 3. patient to be treated with chemotherapy associated with the oral targeted therapy (hormonal therapy is allowed). 4. patient with known risk of fracture, symptomatic cardiac insufficiency (nyha-3), respiratory insufficiency (grade 3), intense pain not controlled with analgesic treatment, and/or neuropathy (grade 3). 5. patients with a history of cancer in the last 5 years (except basal cell carcinoma adequately treated and in situ cervical cancer treated and cured). 6. patient treated with corticotherapy (˃1 month) before randomisation at a dose ˃1 mg/kg. 7. bone metastases with risk of fractures. 8. geographical, sociological, or psychological reasons that could potentially hampering compliance with the study protocol and follow-up schedule. 9. patients with a history of non-compliance to medical treatment, reluctance or incapable to conform to the study protocol. 10. persons deprived of liberty or under guardianship.

Keywords: adapted physical activity oral targeted therapy advanced cancer fatigue quality of life randomized study
multimodal exploration of patients with multiple sclerosis for an early detection of subtle progression

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) is a chronic inflammatory and degenerative disease of the central nervous system (cns), characterized by a complex interplay of inflammatory demyelination and neuronal damage. the core ms phenotypes defined by clinical course are the relapsing and the progressive forms.relapsing ms (rms) is characterized by attacks - also called relapses - defined as new or increasing neurologic dysfunction, followed by periods of partial or complete recovery, without apparent progression of the disease during the periods of remission. in contrast, progressive ms (pms) is characterized by progressive worsening of neurologic function leading to accumulation of disability over time independent of relapses. additional descriptors ("active/not-active") serve to better characterize the presence of clinical and/or radiological activity both in relapsing and progressive forms. in recent years, the concept of a silent progression, also known as smouldering ms, is making its way into the common lexicon of ms experts, challenging the current definitions of ms phenotypes. a growing body of literature suggests that the line between rms and pms is not as marked as men thought, and that inflammation and neurodegeneration can represent a single disease continuum coexisting early on in the disease course. whilst it is established that relapse-associated worsening (raw) can be accounted for by an acute inflammatory focal damage leading to axonal transection and conduction block, the physiopathology underlying the progression independent of relapse activity (pira) remains unclear. it is becoming apparent that there is an increasing need for a personalized therapeutic approach by considering the individual ms phenotype of each patient, thereby enabling the choice of the molecule best suited to counteract the predominant disease pattern of that individual patient. there is a limited number of studies combining clinical scores, neurophysiological evaluation and neuroimaging in patients with ms experiencing pira. integrating a multimodal exploration of these patients might allow a step forward in the early recognition, management, and treatment of disability accumulation independent from relapses in patients with ms.


Eligibility criteria:
inclusion criteria: 1. patients ≥ 18-year-old with diagnosis of rms according to 2017 mcdonald diagnostic criteria 2. availability in the functional outcome database of at least 3 time-point complete evaluations with a time frame from the first to the last evaluation of minimum 12 months 3. most recent functional outcome evaluation within 12 months of enrollment 4. availability of follow-up mri data during the observational period exclusion criteria: a) contraindication to one or more of the paraclinical tests of the prospective multimodal evaluation
a study of women receiving standard of care (soc) for the treatment of pelvic pain due to suspected or confirmed endometriosis and the impact on the disease or symptom progression.

Conditions: Endometriosis; Chronic Pelvic Pain; Dysmenorrhea

Summary: this study will describe historic, current, and evolving treatment pathways, treatments, and interventions in women with a suspected or confirmed diagnosis of endometriosis in order to better understand the impact of early intervention on the disease or its symptoms. length of treatment is dependent on standard of care treatment provided and all study information will be collected during routine standard of care visits.


Eligibility criteria:
inclusion criteria: * women of reproductive age (between their first menstrual cycle and before onset of menopause). * women who have experienced chronic pelvic pain (cpp) and/or dysmenorrhea (dys) for at least 6 months prior to enrollment without symptom improvement with non-steroidal anti-inflammatory drugs (nsaids) or hormone/medical treatment. * women with suspected or confirmed endometriosis (em) at time of enrollment. * women with cpp and/or dys impacting daily activities as determined by their treating physician. * able to read, understand and respond to patient questionnaires. * willing to sign a patient authorization and/or informed consent form (icf) and agree to disclose personal health information. note: for pediatric patients, parental/guardian assent/icf is also required. exclusion criteria: * women with chronic pelvic pain (cpp) and/or dysmenorrhea(dys) for reasons other than endometriosis (em). * women who have had a hysterectomy and/or bilateral ovary removal (oophorectomy). * women who are pregnant or planning to become pregnant. * women currently using assisted reproductive technologies such as in vitro fertilization (ivf). * women with a history of, or current malignancy (with or without systemic chemotherapy) with the exception of basal cell carcinoma of the skin. * women who are currently participating in an interventional clinical trial.

Keywords: endometriosis chronic pelvic pain dysmenorrhea
sd01 registry (sd01 icd lead)

Conditions: Ventricular Fibrillation; Ventricular Tachycardia; Heart Failure

Summary: this registry is designed to gather further evidence, in addition to the sd01 master study, for the safety and efficacy of the sd01 icd lead.


Eligibility criteria:
inclusion criteria: * meet a standard indication for icd/crt-d therapy * first icd/crt-d implantation or upgrade from pacemaker * signed informed consent form * willing to participate for the whole duration of the registry * patient accepts home monitoring concept and is able to activate and use the cardiomessenger * patient has legal capacity and ability to consent exclusion criteria: * meet a standard contraindication for an icd/crt-d therapy * age \<18 years * pregnant or breast-feeding women * cardiac surgery planned within the next six months * enrollment in another cardiac clinical investigation with active treatment arm * mechanical tricuspid valve prosthesis or severe tricuspid valve disease * dexamethasone acetate intolerance

Keywords: icd crt-d lead
vitreous level of tumor necrosis factor alpha in patients with retinal vein occlusion

Conditions: Retinal Vein Occlusion

Summary: to assess the levels of tnf- α in vitreous samples of patients with retinal vein occlusion prior to administration of intravitreal anti-vegf and compare them to levels in vitreous samples of normal subjects so as to investigate the association of vitreous tumor necrosis factor with the pathogenesis of retinal vein occlusion.


Eligibility criteria:
inclusion criteria: * any patient with retinal vein occlusion not older than 6 months with no history of anti-vegf injection exclusion criteria: 1. diabetic patients. 2. other causes of retinal vascular diseases. 3. patients with history of treatment of retinal vein occlusion. 4. previous intraocular surgery except cataract surgery performed 6 months before the study. 5. subjects with severe systemic inflammatory diseases 6. retinal vein occlusion secondary to retinal vasculitis. 7. all retinal pathologies. 8. patients receiving systemic steroids or immunosuppressive therapy.

Keywords: tumor necrosis factor alpha
observatory of patients with haemophilia b treated by idelvion®

Conditions: Haemophilia B

Summary: orphee is a non-interventional, prospective and national study which aim is to record real life data in haemophilia b french patients treated with idelvion® to confirm the efficacy and safety of this product established in clinical development studies.

haemophilia b is a congenital coagulation disorder caused by a deficiency or anomaly of coagulation factor ix (fix). the severity of the haemophilia depends on the extent of the fix deficiency with clinical manifestations differing depending on the location of the bleed. treatment of this disease involves the administration of the deficient factor, i.e. fix, to patients. depending on the severity of the disease and context, a range of treatment regimens are available (long-term prophylactic treatment for the prevention of non-surgical bleeds, short-term prophylactic treatment for high-risk periods, treatment for the prevention of surgical bleeds or on-demand curative treatment). csl behring has developed a long-acting recombinant fix, i.e. rix-fp (idelvion®), to extend the intervals between the administrations of treatment while also providing a therapeutic benefit. data from clinical studies clearly confirm the therapeutic benefit of idelvion® in adult and paediatric patients with haemophilia b previously receiving an on-demand treatment for bleeding episodes, for long-term prophylaxis, as well as in patients undergoing surgery.

Eligibility criteria:
inclusion criteria: * have agreed to participate in the observatory after receiving written information on the purpose of the study and the personal data to be collected (agreement of parents for under-age patients); * present with haemophilia b and are currently being treated or have previously been treated with idelvion® as a long-term prophylactic treatment, on-demand treatment or short-term treatment for surgical procedures or to cover periods with a high-risk of bleeding. * do not have fix targeted antibodies at the time of the inclusion visit exclusion criteria: * refusal by the patient or his/her legal representative to participate in the study; * existence of a contraindication to the use of idelvion® treatment (known hypersensitivity to fix or hamster proteins); * simultaneous participation in an interventional clinical study on a drug

Keywords: fix, coagulation fix
a study with eptinezumab in adolescents (12-17 years) with chronic migraine

Conditions: Chronic Migraine in Children

Summary: to find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

the study includes a single intravenous (iv) infusion of the study drug and consists of a screening period (4 weeks), a double-blind, placebo-controlled period (12 weeks), and a safety follow-up period (8 weeks). participants confirmed eligible will be randomized (1:1:1) to receive a single iv infusion of either eptinezumab 300 milligrams (mg) dose (weight adjusted; targeting adult exposure after 300 mg iv), eptinezumab 100 mg (weight adjusted; targeting adult exposure after 100 mg iv), or placebo at randomization visit. the doses will be adjusted for the participant's body weight.

Eligibility criteria:
inclusion criteria: * the participant has a diagnosis of migraine (with or without aura) as defined by international classification of headache disorders 3 (ichd-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit. * during the 28-day screening period, the participant must adequately complete the headache ediary on at least 23 of the 28 days following the screening visit. * during the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the ediary. exclusion criteria: * the participant has previously been randomised in this study and exposed to eptinezumab. * the participant has been exposed to any monoclonal antibody treatment (including exposure in a study) \<6 months prior to the screening visit. * the participant has been exposed to another calcitonin gene-related peptide (cgrp) antibody (including exposure in a study investigating a cgrp antibody) \<6 months prior to the screening visit. * the participant has a history or diagnosis of complicated migraine (ichd-3 version, 2018), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration; for example \>60 minutes).